Status:
UNKNOWN
Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)
Lead Sponsor:
PEAS (Pole d'Exploration des Apnees du Sommeil)
Conditions:
Syncope, Vasovagal
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population su...
Detailed Description
Treatment for sleep apnoea syndrome includes continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Additional routine follow-up includes 24 hour holter monitoring on a y...
Eligibility Criteria
Inclusion
- Obstructive sleep apnoea syndrome (\>15 respiratory micro awakenings per hour of sleep) with an indication for treatment
- Recurring vasovagal syncope episodes defined as follows: at least three vasovagal syncopes during the last two years - OR- symptoms of orthostatic intolerance occurring in the last 6 months (Symptoms are triggered by orthostatism and can include malaises without loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus, palpitations, headache, limitations of physical activity)
Exclusion
- Pathology that may explain syncope symptoms
- Cardiopathy
- Known disautonomia
- Hypotension of known origin
- Adrenal insufficiency
- Thyroid disorder
- History of sudden death in a first degree family member
Key Trial Info
Start Date :
February 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 22 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04294524
Start Date
February 22 2017
End Date
February 22 2022
Last Update
March 4 2020
Active Locations (8)
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1
University Hospitals of Angers
Angers, France
2
Clinique Bel Air
Bordeaux, France
3
University Hospitals of Bordeaux
Bordeaux, France
4
University Hospitals of Grenoble
Grenoble, France